Kelly Science & Clinical® is seeking a Part-time Travel Clinical Research Coordinator in the East Coast for a contract 6 month with high probability to extend opportunity.
Kelly is working with a Clinical Research Network with a primary focus on Dermatology Phase 2-3 studies.
Job Title : Travel Clinical Research Coordinator
Remote : Contract to hire 20- 30 hrs. Weekly Up to 75% travel
About The Clinical Research Network :
We are launching a multi-specialty Clinical Trials Site Network with a primary focus on dermatology for Phase 2 3 studies.
Our network will expand to cover therapeutic areas such as obesity, diabetes, asthma, hypertension, and neurodegenerative diseases.
Partnering with private physician practices, we aim to initiate and conduct research activities within their practices.
Role Overview :
The Clinical Research Coordinator oversees clinical trials, ensuring compliance with regulatory standards. They manage protocol development, participant recruitment, data collection, collaborating with investigators and sponsors.
Handling site operations, budgets, and contracts, their attention to detail is crucial for maintaining research integrity and advancing medical knowledge.
Responsibilities :
- Conduct feasibility surveys to communicate the capabilities of our clinical trial sites to sponsors and CROs.
- Provide training on International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and International Air Transport Association (IATA) regulations.
- Coordinate space layout and procure necessary equipment for clinical trial sites.
- Develop and implement Standard Operating Procedures (SOPs) for site operations.
- Create and maintain source documents for clinical trials.
- Assist in contract and budget negotiations with sponsors and vendors.
- Prepare and submit regulatory documents for Institutional Review Board (IRB) approval, both for Investigator-Initiated Trials (IIT) and sponsor-initiated trials.
- Configure technology systems such as CRIO Veeva SiteVault for eSource and other CTMS.
- Collaborate with cross-functional teams including investigators, sponsors, and regulatory authorities.
- Manage projects and ensure attention to detail throughout the clinical trial process.
Qualifications :
- Bachelor’s degree in a scientific or health care discipline preferred or equivalent combination of education and experience.
- 2-5 years' experience as a clinical research coordinator
- Competency in FDA / ISO / ICH / GCP regulations / compliance
- Strong project management skills, data management skills
- Ability to work with cross-functional teams
- Proficiency in using clinical trial software and tools
- Detail-oriented, with a focus on data accuracy and compliance
Travel Requirements :
- Able to travel via airplane, train, or motor vehicle to respective research sites or investigator meetings.
- Must be able to travel out of the local office or from home up to 75% of the time, including overnight stays at hotels or other designated facilities.
- Must be able to drive and have a valid driver’s license.
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Science & Clinical?
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